Borderless Regulatory Intelligence
Today’s healthcare market demands a coordinated yet flexible global strategy. Our international regulatory experts convert regional requirements into harmonized approaches, providing the strategic foresight and exceptional adaptability needed to navigate diverse approval pathways with precision and efficiency.
Strategic Global Planning
We create synchronized regulatory strategies across international markets, optimizing resource allocation while identifying opportunities for streamlined evidence generation and submission efficiencies. Our approach maintains the flexibility to adapt as regional requirements evolve.
- Integrated global regulatory roadmap development with market prioritization
- Regional regulatory landscape assessment with competitive analysis
- Multi-market classification strategy with harmonized approach
- International evidence generation planning with unified protocol development
- Cross-market submission optimization
- Regulatory resource allocation strategy across priority markets
Regional Expertise Application
We deliver MedTech regulatory guidance for key international markets, applying deep understanding of regional requirements and approval processes to secure efficient market access across diverse regulatory environments.
- EU MDR/IVDR compliance strategy and implementation
- UK post-Brexit regulatory navigation and UKCA marking
- Health Canada Medical Device License application preparation
- PMDA (Japan) registration strategy and submission management
- TGA (Australia) market entry planning and application development
- NMPA (China) regulatory approach and pathway selection
Synchronized Submission Management
Our coordinated approach maintains perfect alignment across international submissions, ensuring consistent positioning for your medical technology while adapting to regional requirements for maximum approval efficiency.
- Harmonized technical documentation preparation (STED/IMDRF format)
- Regional submission adaptation with market-specific customization
- Synchronized international submission tracking and management
- Coordinated responses to authority questions across markets
- Global regulatory intelligence monitoring with impact assessment
International Lifecycle Management
We maintain regulatory compliance across global markets throughout your MedTech product lifecycle, efficiently managing post-approval changes and market-specific maintenance requirements with the agility to respond to evolving international regulations.
- Multi-market post-approval change management
- Harmonized label expansion strategy across international regions
- International annual reporting and renewal coordination
- Global post-market surveillance system development
- Regional vigilance reporting compliance
- International supply chain regulatory management
Regulatory Expertise & Intelligence
Across the Globe
Beaufort provides strategic, region-specific regulatory guidance that helps you transform complex regulatory demands into accelerated approvals across every major MedTech market.
-
Global Knowledge, Local Precision
Our regional specialists bring market-specific insights that transform regulatory requirements into strategic advantage, with tailored approaches for each international territory. -
EMEA (Europe, Middle East, Africa)
Our EMEA specialists navigate the complex MDR/IVDR landscape, providing strategic guidance on Notified Body selection, conformity assessment pathways, and technical documentation preparation that streamlines European market access while addressing regional variations. -
United Kingdom
Our UK regulatory team provides essential guidance navigating the post-Brexit regulatory environment, offering comprehensive UKCA marking strategies, UK Responsible Person support, and seamless transition planning that ensures continuous market access. -
Asia-Pacific (APAC)
Our APAC regulatory experts deliver strategic approaches to diverse regional requirements, from PMDA registration in Japan to TGA applications in Australia, providing country-specific strategies that optimize evidence generation and accelerate market entry timelines. -
Latin America (LATAM)
Our LATAM specialists navigate complex regional approval processes with strategic guidance on ANVISA registration in Brazil, COFEPRIS submission in Mexico, and harmonized approaches that leverage reference market approvals for expedited pathways. -
Canada
Our Canadian regulatory strategists provide comprehensive guidance on Health Canada requirements, offering expertise in Medical Device License applications, Special Access Programs, and Investigational Testing Authorizations that accelerate market entry with strategic precision.
Our Clients Recognize the Beaufort Difference
-
They came into our company which didn’t have a lot of experience in executing clinical studies for diagnostic products and helped us draft protocols, assisted with submission decisions, and gave us the guidance that we would not have otherwise known we needed. And it was just phenomenal to be able to work with them that way.
Your Global Regulatory Partner for MedTech
Navigate global requirements for your medical technology with confidence. Get expert guidance, harmonized strategy, and local insight to streamline international MedTech approvals.
News & Insights
Access our expert insights across a breadth of clinical challenges—
from evolving global regulations to the latest practice guidelines—that
are shaping tomorrow’s MedTech landscape.
